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JMU
JMU DENTAL, INC · Model 21502003 · UDI-DI 00840456220443
10
510(k) clearances
3,963
Adverse events
3
Recalls
165
Facilities
Description
JMU Hand Use C+ Files, stainless steel, sizes #08 × 2, #10 × 2, #15 × 2 (25 mm), non-sterile, packed 6 pieces per card. Sold by card.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-02 | US Endodontics, LLC | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| 2012-12-12 | Ormco/Sybronendo | The length markings on the Lightspeed LSX files were wrong. |
| 2008-08-01 | Ormco Corporation | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.